Mild to Moderate PsoriasisPhase 1NCT02529956
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of UCB4940 in Patients With Psoriasis
A Phase 1 study testing UCB4940 in people with Mild to Moderate Psoriasis, run by UCB Celltech at 1 site in United Kingdom.
Trial summary
To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mild to Moderate Psoriasis
- What is being tested?
- UCB4940
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Jan 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male or female, aged ≥ 18 years to ≤ 70 years at Screening. Female subjects must either be postmenopausal (at least 1 year), permanently sterilized or, if of childbearing potential, must be willing to use at least 2 effective methods of contraception, including a barrier method during the study period. Effective methods of contraception are methods of birth control, which result in a low failure rate when used consistently and correctly, such as implants, injectables, oral contraceptives, progesterone-releasing intrauterine systems or the TCu 380A intrauterine device, complete sexual abstinence, or vasectomized partner. Male subjects with partners of childbearing potential must be willing to use a condom when sexually active. Both male and female subjects must use the above mentioned contraception for 20 weeks after administration of study drug (anticipated 5 half-lives)
- Subject has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving ≤ 5 % of body surface area (BSA) (excluding the scalp)
- Subject has a body mass index of ≤ 35 kg/m^2 at Screening
- Subject has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy
Who cannot join
- Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method
- Subject has received systemic nonbiologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening
- Subject has received treatment with biologic agents within 12 months prior to the study
- Subject has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study
- Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to IMP administration
- Subject requires treatment with a nonsteroidal anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic
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- Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration. When in doubt, the Investigator should confer with the UCB Study Physician
- Subject has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening that cannot be attributed to a prior Bacillus Calmette-Guérin inoculation
- Subject has renal or liver impairment, defined as:
- For women, serum creatinine level ≥ 125 μmol/L; for men, ≥ 135 μmol/L, or
- ALT and aspartate aminotransferase ≥ 2x ULN, or
- Alkaline phosphatase and bilirubin > 1.5x ULN (an isolated bilirubin > 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35 %)
- Subject has active neoplastic disease or history of neoplastic disease within 5 years of Screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Subject-blind, Investigator-blind, Placebo-controlled, Single-dose, Dose-escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB4940 in Patients With Mild to Moderate Psoriasis
To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.
- Conditions
- Mild to Moderate Psoriasis
- Being tested
- UCB4940, Placebo
- Keywords
- Psoriasis, UCB4940
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB4940Drug
- Active Substance: UCB4940
- Pharmaceutical Form: Solution for infusion
- Concentration: 80 mg/ml
- Route of Administration: Intravenous use
PlaceboOther
- Active Substance: Placebo
- Pharmaceutical Form: Solution for infusion
- Concentration: 0.9 % sodium chloride aqueous solution
- Route of Administration: Intravenous use
| Study group | Role | What they receive |
|---|---|---|
| UCB4940 8 mg | Experimental | Single intravenous (iv) infusion of UCB4940 8 mg over at least 60 minutes. Receives: Drug: UCB4940 |
| UCB4940 40 mg | Experimental | Single intravenous (iv) infusion of UCB4940 40 mg over at least 60 minutes. Receives: Drug: UCB4940 |
| UCB4940 160 mg | Experimental | Single intravenous (iv) infusion of UCB4940 160 mg over at least 60 minutes. Receives: Drug: UCB4940 |
| UCB4940 480 mg | Experimental | Single intravenous (iv) infusion of UCB4940 480 mg over at least 60 minutes. Receives: Drug: UCB4940 |
| UCB4940 640 mg | Experimental | Single intravenous (iv) infusion of UCB4940 640 mg over at least 60 minutes. Receives: Drug: UCB4940 |
| Placebo | Placebo comparator | Single intravenous (iv) infusion of Placebo over at least 60 minutes. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)
Measured: Baseline to 20 Weeks
Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)
Measured: Baseline to 20 Weeks
Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks)
Measured: Baseline to 20 Weeks
Secondary outcomes (13)
Maximum plasma concentration (Cmax)
Measured: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-inf))
Measured: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC(0-t))
Measured: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Time to reach Cmax (Tmax)
Measured: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Terminal elimination half-life (t1/2)
Measured: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
First order terminal elimination rate constant (λz)
Measured: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Total body clearance (CL)
Measured: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Volume of distribution in terminal phase (Vz)
Measured: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Percentage Change from Baseline to Week 12 in the Lesion Severity Score (LSS)
Measured: Baseline to Week 12
Percentage Change from Baseline to Week 12 in thickness of the plaque
Measured: Baseline to Week 12
Percentage Change from Baseline to Week 12 in lesion area
Measured: Baseline to Week 12
Percentage Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)
Measured: Baseline to Week 12
Percentage Change from Baseline to Week 12 in Physician's Global Assessment (PGA)
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startNov 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Celltech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 8229493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529956
- Sponsor's protocol ID
- UP0008
- Other IDs
- 2012-002086-35
- Status last verified
- Aug 2015
- First submitted
- 19 Aug 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Glatt S, Helmer E, Haier B, Strimenopoulou F, Price G, Vajjah P, Harari OA, Lambert J, Shaw S. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017 May;83(5):991-1001. doi: 10.1111/bcp.13185. Epub 2017 Jan 10.
PubMed 27859546
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Subject-blind, Investigator-blind, Placebo-controlled, Single-dose, Dose-escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB4940 in Patients With Mild to Moderate Psoriasis
- ClinicalTrials.gov ID
- NCT02529956
- Acronym / sponsor ID
- UP0008
- Conditions
- Mild to Moderate Psoriasis
- Keywords
- Psoriasis, UCB4940
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- UCB CelltechIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| UCB4940 8 mg | Experimental | Drug: UCB4940Single intravenous (iv) infusion of UCB4940 8 mg over at least 60 minutes. |
| UCB4940 40 mg | Experimental | Drug: UCB4940Single intravenous (iv) infusion of UCB4940 40 mg over at least 60 minutes. |
| UCB4940 160 mg | Experimental | Drug: UCB4940Single intravenous (iv) infusion of UCB4940 160 mg over at least 60 minutes. |
| UCB4940 480 mg | Experimental | Drug: UCB4940Single intravenous (iv) infusion of UCB4940 480 mg over at least 60 minutes. |
| UCB4940 640 mg | Experimental | Drug: UCB4940Single intravenous (iv) infusion of UCB4940 640 mg over at least 60 minutes. |
| Placebo | Placebo comparator | Other: PlaceboSingle intravenous (iv) infusion of Placebo over at least 60 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is male or female, aged ≥ 18 years to ≤ 70 years at Screening. Female subjects must either be postmenopausal (at least 1 year), permanently sterilized or, if of childbearing potential, must be willing to use at least 2 effective methods of contraception, including a barrier method during the study period. Effective methods of contraception are methods of birth control, which result in a low failure rate when used consistently and correctly, such as implants, injectables, oral contraceptives, progesterone-releasing intrauterine systems or the TCu 380A intrauterine device, complete sexual abstinence, or vasectomized partner. Male subjects with partners of childbearing potential must be willing to use a condom when sexually active. Both male and female subjects must use the above mentioned contraception for 20 weeks after administration of study drug (anticipated 5 half-lives)
- Subject has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving ≤ 5 % of body surface area (BSA) (excluding the scalp)
- Subject has a body mass index of ≤ 35 kg/m^2 at Screening
- Subject has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy
Key exclusion criteria (13 listed)
- Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method
- Subject has received systemic nonbiologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening
- Subject has received treatment with biologic agents within 12 months prior to the study
- Subject has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study
- Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to IMP administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCB4940* Active Substance: UCB4940 * Pharmaceutical Form: Solution for infusion * Concentration: 80 mg/ml * Route of Administration: Intravenous use | Drug | UCB4940 160 mg, UCB4940 40 mg, UCB4940 480 mg, UCB4940 640 mg, UCB4940 8 mg |
| Placebo* Active Substance: Placebo * Pharmaceutical Form: Solution for infusion * Concentration: 0.9 % sodium chloride aqueous solution * Route of Administration: Intravenous use | Other | Placebo |
Primary outcome
Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)
Time frame: Baseline to 20 Weeks
Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)
Time frame: Baseline to 20 Weeks
Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks)
Time frame: Baseline to 20 Weeks
13 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-inf))
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC(0-t))
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Time to reach Cmax (Tmax)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Terminal elimination half-life (t1/2)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
First order terminal elimination rate constant (λz)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Total body clearance (CL)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Volume of distribution in terminal phase (Vz)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Percentage Change from Baseline to Week 12 in the Lesion Severity Score (LSS)
Time frame: Baseline to Week 12
Percentage Change from Baseline to Week 12 in thickness of the plaque
Time frame: Baseline to Week 12
Percentage Change from Baseline to Week 12 in lesion area
Time frame: Baseline to Week 12
Percentage Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline to Week 12
Percentage Change from Baseline to Week 12 in Physician's Global Assessment (PGA)
Time frame: Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Derived from this study: PubMed 27859546Glatt S, Helmer E, Haier B, Strimenopoulou F, Price G, Vajjah P, Harari OA, Lambert J, Shaw S. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017 May;83(5):991-1001. doi: 10.1111/bcp.13185. Epub 2017 Jan 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 8229493 (UCB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UCB4940 in people with Mild to Moderate Psoriasis, run by UCB Celltech at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (time frame: Baseline to 20 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.